Repositioning of prosthetic heart valve and deployment

ABSTRACT

A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent has an annulus section with a relatively small cross-section, and an aortic section with a relatively large cross-section. The valve assembly, including a cuff and a plurality of leaflets, is secured to the stent in the annulus section such that the valve assembly can be entirely deployed in the native valve annulus and function as intended while at least a portion of the aortic section is held by the delivery device in a manner that allows for resheathing. The configuration of the prosthetic valve is such that the valve leaflets can fully coapt and the valve can function properly even when the stent and/or valve assembly become distorted upon deployment or use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/215,901 filed Aug. 23, 2011, which claims the benefit of the filingdate of U.S. Provisional Patent Application No. 61/438,451 filed Feb. 1,2011, the disclosures of which are hereby incorporated herein byreference.

BACKGROUND OF THE INVENTION

The present invention relates to heart valve replacement and, inparticular, to collapsible prosthetic heart valves. More particularly,the present invention relates to collapsible prosthetic heart valvesthat may be repositioned during the deployment procedure.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalve structures are ordinarily mounted: a self-expanding stent and aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, assuring its properlocation, and then expanding a balloon positioned within the valvestent. For self-expanding valves, on the other hand, the stentautomatically expands as the sheath covering the valve is withdrawn.

In conventional delivery systems for self-expanding aortic valves, forexample, after the delivery system has been positioned for deployment,the annulus end of the valve is typically unsheathed and expanded first,while the aortic end of the valve remains sheathed. Once the annulus endof the valve has expanded, it may be determined that the valve needs tobe repositioned in the patient's aortic annulus. To accomplish this, auser (such as a surgeon or an interventional cardiologist) typicallyresheaths the annulus end of the valve, so that the valve can berepositioned while in a collapsed state. After the valve has beenrepositioned, the user can again release the valve.

Once a self-expanding valve has been fully deployed, it expands to adiameter larger than that of the sheath that previously contained thevalve in the collapsed condition, making resheathing impossible, ordifficult at best. In order for the user to be able to more readilyresheath a valve, it is preferable that the valve be only partiallydeployed, with a portion of the valve still collapsed inside of thesheath.

Despite the various improvements that have been made to the collapsibleprosthetic heart valve delivery process, conventional delivery devices,systems, and methods suffer from some shortcomings. For example, inconventional delivery devices for self-expanding valves, it is difficultto control how much of the valve remains in the sheath during a partialdeployment, and the user may accidentally deploy the valve fully beforeverifying that the annulus end of the valve is in the optimal positionin the patient's valve annulus, thereby taking away the opportunity toresheath and reposition the valve. Moreover, it is not possible at thistime to determine whether a valve assembly will function as intendedwithout full deployment of the heart valve. Due to anatomical variationsbetween patients, a fully deployed heart valve may need to be removedfrom the patient if it appears that the valve is not functioningproperly. Removing a fully deployed heart valve increases the length ofthe procedure and increases the risk of infection and/or damage to hearttissue.

There therefore is a need for further improvements to the devices,systems, and methods for transcatheter delivery of collapsibleprosthetic heart valves, and in particular, self-expanding prostheticheart valves. Among other advantages, the present invention may addressone or more of these needs.

SUMMARY OF THE INVENTION

One aspect of the disclosure provides a prosthetic heart valve includinga collapsible and expandable stent having a proximal end, a distal end,an annulus section adjacent the proximal end and an aortic sectionadjacent the distal end. The annulus section has a first expandedcross-section and the aortic section has a second expanded cross-sectionlarger than the first expanded cross-section. A plurality of commissurepoints are disposed in the annulus section. A collapsible and expandablevalve assembly is disposed entirely within the annulus section betweenthe proximal end of the stent and the plurality of commissure points.The valve assembly includes a plurality of leaflets connected to theplurality of commissure points. The plurality of commissure points arespaced from the distal end of the stent by a selected distance such thatthe prosthetic valve can be partially deployed from a delivery device ata target site by withdrawing a portion of the sheath of the deliverydevice from around the prosthetic valve, and the valve assembly canfunction as intended while the distal end of the stent is held withinthe sheath of the delivery device in a manner that enables resheathing.

In one example, a plurality of commissure points are spaced at aselected distance of about two-thirds of the length of the stent fromthe proximal end to the distal end. In another example, the plurality ofleaflets have an open condition in which the leaflets are spaced apartfrom one another to define a flow passageway through the stent, and aclosed condition in which the leaflets coapt to occlude the flowpassageway, the leaflets being disposed completely within the annulussection in both the open and closed conditions. In another example, thevalve assembly further includes a cuff disposed in the annulus section.In yet another example, the cuff is disposed on a lumenal surface of theannulus section. Alternatively, the cuff is disposed on an ablumenalsurface of the annulus section. The plurality of leaflets may includetwo or three leaflets.

In another aspect, the prosthetic heart valve includes a collapsible andexpandable stent having a proximal end, a distal end, an annulus sectionadjacent the proximal end, an aortic section adjacent the distal end,and a transition section between the aortic section and the annulussection. The annulus section has a first expanded cross-section, and theaortic section has a second expanded cross-section larger than the firstexpanded cross-section. The transition section has an expandedcross-section which transitions from the first expanded cross-section tothe second expanded cross-section. A plurality of commissure points isdisposed at a juncture between the annulus section and the transitionsection. A collapsible and expandable valve assembly is disposedentirely within the annulus section between the proximal end of thestent and the plurality of commissure points, the valve assemblyincluding a plurality of leaflets connected to the plurality ofcommissure points. The plurality of commissure points are spaced fromthe distal end of the stent by a selected distance such that theprosthetic valve can be partially deployed from a delivery device at atarget site by withdrawing a portion of the sheath of the deliverydevice from around the prosthetic valve, and the valve assembly canfunction as intended while the distal end of the stent is held withinthe sheath of the delivery device in a manner that enables resheathing.

In another aspect, a prosthetic heart valve includes a collapsible andexpandable stent having a proximal end, a distal end, an annulus sectionadjacent the proximal end and an aortic section adjacent the distal end.The annulus section has a first expanded cross-section and anunconstrained shape and the aortic section has a second expandedcross-section larger than the first expanded cross-section. A pluralityof commissure points are disposed in the annulus section. A collapsibleand expandable valve assembly is disposed entirely within the annulussection between the proximal end of the stent and the plurality ofcommissure points. The valve assembly includes a plurality of leafletsconnected to the plurality of commissure points, the plurality ofleaflets having an open condition in which the leaflets are spread apartfrom one another to define a flow passageway through the stent, and aclosed condition in which the leaflets form coaptation sections toocclude the flow passageway. The coaptation sections occlude the flowpassageway both when the annulus section has the unconstrained shape andwhen the annulus section is distorted from the unconstrained shape.

In one example, the coaptation sections are oriented substantiallyparallel to a longitudinal axis of the stent in the closed condition. Inanother example, each coaptation section has a length in a directionfrom a free-edge of a leaflet toward the stent, the length being betweenabout 1 mm and about 5 mm. In another example, each of the plurality ofleaflets forms a belly contour before converging at the coaptationsection in the closed condition. In another example, each of theplurality of leaflets forms a flat belly before converging at thecoaptation section in the closed condition.

In one aspect the disclosure provides a method of deploying a prostheticheart valve at a target site. The method includes introducing a deliverydevice to the target site, the delivery device housing a prostheticheart valve in a collapsed condition and having an outer sheathsurrounding the prosthetic heart valve. The prosthetic heart valveincludes a collapsible and expandable stent having a proximal end, adistal end, an annulus section adjacent the proximal end and an aorticsection adjacent the distal end. The heart valve further includes aplurality of commissure points disposed in the annulus section and acollapsible and expandable valve assembly disposed entirely within theannulus section between the proximal end of the stent and the pluralityof commissure points. The method further includes withdrawing the sheatha first distance to partially deploy the prosthetic heart valve at thetarget site, the prosthetic heart valve being deployed from the proximalend of the stent toward the distal end of the stent such that the valveassembly is fully deployed at the first distance and can function asintended while the distal end of the stent is held within the sheath ofthe delivery device. The sheath is fully withdrawn to fully deploy theprosthetic heart valve.

In another aspect the disclosure provides a method of deploying aprosthetic heart valve at a target site. The method includes introducinga delivery device to the target site, the delivery device housing aprosthetic heart valve in a collapsed condition and having an outersheath surrounding the prosthetic heart valve. The prosthetic heartvalve includes a collapsible and expandable stent having a proximal end,a distal end, an annulus section adjacent the proximal end and an aorticsection adjacent the distal end, a plurality of commissure pointsdisposed in the annulus section, and a collapsible and expandable valveassembly disposed entirely within the annulus section between theproximal end of the stent and the plurality of commissure points. Themethod further includes withdrawing the sheath a first distance topartially deploy the prosthetic heart valve at the target site, theprosthetic heart valve being deployed from the proximal end of the stenttoward the distal end of the stent such that the valve assembly is fullydeployed at the first distance and can function as intended while thedistal end of the stent is held within the sheath of the deliverydevice. The prosthetic heart valve is resheathed and the sheath iswithdrawn a first distance to partially deploy the prosthetic heartvalve at the target site, the prosthetic heart valve being deployed fromthe proximal end of the stent toward the distal end of the stent suchthat the valve assembly is fully deployed at the first distance and canfunction as intended while the distal end of the stent is held withinthe sheath of the delivery device.

In one example, the sheath is withdrawn so as to fully deploy theprosthetic heart valve. In another example, the valve assembly includesa plurality of leaflets connected to the plurality of commissure points,the plurality of leaflets having an open condition in which the leafletsare spaced apart from one another to define a flow passageway throughthe stent, and a closed condition in which the leaflets coapt to occludethe flow passageway and the valve assembly functions as intended byproviding adequate coaptation by the leaflets in the closed condition.In another example, partially deploying the prosthetic heart valveincludes withdrawing the sheath to uncover only the annulus section ofthe heart valve and fully deploying the heart valve includes withdrawingthe sheath to uncover both the annulus section and the aortic section ofthe heart valve. In another example, the valve assembly includes aplurality of leaflets connected to the plurality of commissure points,the plurality of leaflets having an open condition in which the leafletsare spaced apart from one another to define a flow passageway throughthe stent, and a closed condition in which the leaflets coapt to occludethe flow passageway and the plurality of leaflets can fully coapt whenthe heart valve is partially deployed at the target site. In anotherexample, the plurality of leaflets are capable of forming coaptationsections to occlude the flow passageway, the coaptation sectionsoccluding the flow passageway both when the annulus section has theunconstrained shape and when the annulus section is distorted from theunconstrained shape.

In another aspect, the disclosure provides a method of testing theoperability of a prosthetic heart valve at a target site. The methodincludes introducing a delivery device to the target site, the deliverydevice housing a prosthetic heart valve in a collapsed condition andhaving an outer sheath surrounding the prosthetic heart valve. Theprosthetic heart valve includes a collapsible and expandable stenthaving a proximal end, a distal end, an annulus section adjacent theproximal end and an aortic section adjacent the distal end, a pluralityof commissure points disposed in the annulus section, and a collapsibleand expandable valve assembly disposed entirely within the annulussection between the proximal end of the stent and the plurality ofcommissure points. The sheath is withdrawn a first distance to partiallydeploy the prosthetic heart valve at the target site, the prostheticheart valve being deployed from the proximal end of the stent toward thedistal end of the stent such that the valve assembly is fully deployedat the first distance and can function as intended while the distal endof the stent is held within the sheath of the delivery device. Valvefunction is assessed when the prosthetic heart valve is partiallydeployed. The prosthetic heart valve can be resheathed.

In one example, introducing the delivery device to the target siteincludes introducing the delivery device to a target site in vitro. Inanother example, introducing the delivery device to the target siteincludes introducing the delivery device to a target site in a mammal.In another example, introducing the delivery device to the target siteincludes introducing the delivery device to a target site in a humanpatient.

In another aspect, the disclosure provides a system including aprosthetic heart valve including a collapsible and expandable stenthaving a proximal end, a distal end, an annulus section adjacent theproximal end and an aortic section adjacent the distal end. The annulussection has a first expanded cross-section and the aortic section has asecond expanded cross-section larger than the first expandedcross-section. A plurality of commissure points are disposed in theannulus section, and a collapsible and expandable valve assembly isdisposed entirely within the annulus section between the proximal end ofthe stent and the plurality of commissure points. The valve assemblyincludes a plurality of leaflets connected to the plurality ofcommissure points, the plurality of commissure points being spaced fromthe distal end of the stent by a selected distance such that theprosthetic valve can be partially deployed from a delivery device at atarget site by withdrawing a sheath of the delivery device from aroundthe prosthetic valve. The delivery device includes a sheath partiallycovering the stent and releasably retaining same, wherein the valveassembly is free to operate in a portion of the stent not retained bythe sheath.

In another aspect, the disclosure provides a system including aprosthetic heart valve having a collapsible and expandable stent havinga proximal end, a distal end, an annulus section adjacent the proximalend and an aortic section adjacent the distal end. The annulus sectionhas a first expanded cross-section and the aortic section has a secondexpanded cross-section larger than the first expanded cross-section. Aplurality of commissure points are disposed in the annulus section, anda collapsible and expandable valve assembly is disposed entirely withinthe annulus section between the proximal end of the stent and theplurality of commissure points. The valve assembly includes a pluralityof leaflets connected to the plurality of commissure points, theplurality of commissure points being spaced from the distal end of thestent by a selected distance such that the prosthetic valve can bepartially deployed from a delivery device at a target site bywithdrawing a sheath of the delivery device from around the prostheticvalve. The system further includes a delivery device having a sheathcapable of being moved from a first configuration in which the sheathpartially covers the stent and releasably retains same, wherein thevalve assembly is free to operate in a portion of the stent not retainedby the sheath, and a second configuration in which the sheathsubstantially completely covers the stent and the valve assembly isincapable of normal function.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed delivery system aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a partial side elevational view of a prosthetic heart valveincluding a valve assembly and a stent;

FIG. 2 is a partial side elevational view of a collapsible prostheticheart valve according to an embodiment of the present invention, showingthe valve assembly attached to the stent;

FIG. 3A is a side elevational view showing partial deployment of acollapsible prosthetic heart valve with high placement;

FIG. 3B is a side elevational view showing partial deployment of acollapsible prosthetic heart valve with low placement;

FIG. 4A is a side elevational view of a conventional collapsibleprosthetic heart valve;

FIG. 4B is a side elevational view of a collapsible prosthetic heartvalve according to the present invention;

FIG. 5 is an end view of the prosthetic heart valve of FIG. 2 as seenfrom the aortic sinus toward the heart and the native valve annulus, thevalve being disposed in a circular configuration;

FIG. 6 is an end view of the prosthetic heart valve of FIG. 2 as seenfrom the aortic sinus toward the heart and the native valve annulus, thevalve being disposed in an elliptical configuration;

FIG. 7A is an end view of the prosthetic heart valve of FIG. 2 in afirst configuration as seen from the aorta or aortic sinus toward theheart and the native valve annulus;

FIG. 7B is an end view of the prosthetic heart valve of FIG. 2 in asecond configuration as seen from the aorta or aortic sinus toward theheart and the native valve annulus;

FIG. 7C is an end view of the prosthetic heart valve disposed in theconfiguration of FIG. 7A as seen from the left ventrical, looking uptoward the aortic sinus;

FIG. 7D is an end view of the prosthetic heart valve disposed in theconfiguration of FIG. 7B as seen from the left ventrical, looking uptoward the aortic sinus;

FIG. 8A is an end view of a conventional prosthetic heart valve having ashallow belly contour illustrating inadequate coaptation;

FIG. 8B is a side elevational view of the conventional prosthetic heartvalve of FIG. 8A showing inadequate coaptation;

FIG. 8C is an end view of one embodiment of a prosthetic heart valvehaving a belly contour according to the present invention showingsuperior coaptation;

FIG. 8D is a side elevational view of the prosthetic heart valve of FIG.8C showing superior coaptation;

FIG. 9A is an end view of a conventional prosthetic heart valve having aflat belly illustrating inadequate coaptation;

FIG. 9B is a side elevational view of the conventional prosthetic heartvalve of FIG. 9A showing inadequate coaptation;

FIG. 9C is an end view of one embodiment of a prosthetic heart valvehaving a flat belly according to the present invention showing superiorcoaptation;

FIG. 9D is a side elevational view of the prosthetic heart valve of FIG.9C showing superior coaptation;

FIG. 10 is a side elevational view of a prosthetic heart valve havingextended coaptation sections with free edges that interfere withcoaptation;

FIG. 11 is a perspective view of an operating handle for a transfemoraldelivery device for a collapsible prosthetic heart valve, shown with aside elevational view of the distal portion of a transfemoral catheterassembly;

FIG. 12 is a top plan view of the handle of FIG. 11;

FIG. 13 is an enlarged perspective view of the carriage assembly of thehandle of FIG. 11;

FIG. 14 is an enlarged bottom perspective view of a portion of thehandle of FIG. 11;

FIG. 15 is an enlarged bottom plan view of the portion of the handleshown in FIG. 14, shown with a transparent carriage assembly;

FIG. 16 is an enlarged perspective view of a portion of the handle ofFIG. 11, shown without the carriage assembly;

FIG. 17 is an enlarged perspective view of the locking member of thehandle shown in FIG. 16;

FIG. 18 is an enlarged bottom plan view of a portion of a handle inaccordance with another embodiment of the present invention, suitablefor use with the transfemoral catheter assembly of FIG. 11;

FIG. 19 is a diagrammatic top plan view of another embodiment of ahandle suitable for use with the transfemoral catheter assembly of FIG.11;

FIG. 20 is a diagrammatic top plan view of a further embodiment of ahandle suitable for use with the transfemoral catheter assembly of FIG.11;

FIG. 21 is a diagrammatic top plan view of yet another embodiment of ahandle suitable for use with the transfemoral catheter assembly of FIG.11; and

FIG. 22 is a diagrammatic top plan view of an operating handle for atransapical delivery device for a collapsible prosthetic heart valve,shown with a side elevational view of the distal portion of atransapical catheter assembly.

Various embodiments of the present invention will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “proximal,” when used in connection with aprosthetic heart valve, refers to the end of the heart valve closest tothe heart when the heart valve is implanted in a patient, whereas theterm “distal,” when used in connection with a prosthetic heart valve,refers to the end of the heart valve farthest from the heart when theheart valve is implanted in a patient. When used in connection withdevices for delivering a prosthetic heart valve into a patient, theterms “proximal” and “distal” are to be taken as relative to the user ofthe delivery devices. “Proximal” is to be understood as relatively closeto the user, and “distal” is to be understood as relatively farther awayfrom the user.

FIG. 1 shows a collapsible prosthetic heart valve 100 according to anembodiment of the present disclosure. The prosthetic heart valve 100 isdesigned to replace the function of a native aortic valve of a patient.Examples of collapsible prosthetic heart valves are described inInternational Patent Application Publication No. WO/2009/042196; U.S.Pat. No. 7,018,406; and U.S. Pat. No. 7,329,278, the disclosures of allof which are hereby incorporated herein by reference. As discussed indetail below, the prosthetic heart valve has an expanded condition and acollapsed condition. Although the invention is described herein asapplied to a prosthetic heart valve for replacing a native aortic valve,the invention is not so limited, and may be applied to prosthetic valvesfor replacing other types of cardiac valves.

The prosthetic heart valve 100 includes a stent or frame 102, which maybe wholly or partly formed of any biocompatible material, such asmetals, synthetic polymers, or biopolymers capable of functioning as astent. Suitable biopolymers include, but are not limited to, elastin,and mixtures or composites thereof. Suitable metals include, but are notlimited to, cobalt, titanium, nickel, chromium, stainless steel, andalloys thereof, including nitinol. Suitable synthetic polymers for useas a stent include, but are not limited to, thermoplastics, such aspolyolefins, polyesters, polyamides, polysulfones, acrylics,polyacrylonitriles, polyetheretherketone (PEEK), and polyaramides. Thestent 102 may have an annulus section 110 and an aortic section (notshown). Each of the annulus section 110 and the aortic section of thestent 102 includes a plurality of cells 112 connected to one anotheraround the stent. The annulus section 110 and the aortic section of thestent 102 may include one or more annular rows of cells 112 connected toone another. For instance, the annulus section 110 may have two annularrows of cells 112. When the prosthetic heart valve 100 is in theexpanded condition, each cell 112 may be substantially diamond shaped.Regardless of its shape, each cell 112 is formed by a plurality ofstruts 114. For example, a cell 112 may be formed by four struts 114.

The stent 102 may include commissure points 116 connecting at least twocells 112 in the longitudinal direction of the stent 102. The commissurepoints 116 may include eyelets for facilitating the suturing of a valveassembly 104 to the stent 102.

The prosthetic heart valve 100 also includes a valve assembly 104attached inside the annulus section 110 of the stent 102. United StatesPatent Application Publication No. 2008/0228264, filed Mar. 12, 2007,and United States Patent Application Publication No. 2008/0147179, filedDec. 19, 2007, the entire disclosures of both of which are herebyincorporated herein by reference, describe suitable valve assemblies.The valve assembly 104 may be wholly or partly formed of any suitablebiological material or polymer. Examples of biological materialssuitable for the valve assembly 104 include, but are not limited to,porcine or bovine pericardial tissue. Examples of polymers suitable forthe valve assembly 104 include, but are not limited to, polyurethane andpolyester. In some embodiments, the cuff and/or the sutures may includeultra-high-molecular-weight polyethylene.

The valve assembly 104 may include a cuff 106 disposed on the lumenalsurface of annulus section 110, on the ablumenal surface of annulussection 110, or on both surfaces, and the cuff may cover all or part ofeither or both of the lumenal and ablumenal surfaces of the annulussection. FIG. 1 shows cuff 106 disposed on the lumenal surface ofannulus section 110 so as to cover part of the annulus section whileleaving another part thereof uncovered. The valve assembly 104 mayfurther include a plurality of leaflets 108 which collectively functionas a one-way valve. A first edge 122 of each leaflet 108 may be attachedto the stent 102 by any suitable attachment means, such as suturing,stapling, adhesives or the like. For example, the first edge 122 of eachleaflet 108 may be sutured to the stent 102 by passing strings orsutures through the cuff 106 of the valve assembly 104. A second or freeedge 124 of each leaflet 108 may coapt with the corresponding free edgesof the other leaflets, thereby enabling the leaflets to functioncollectively as a one-way valve. Thus, the leaflets 108 may be attachedto the stent 102 along at least some struts 114 of the stent to enhancethe structural integrity of the valve assembly 104.

As shown in FIG. 1, at least one leaflet 108 may be attached to thestent 102 so that its first edge 122 is disposed substantially alongspecific struts 114 a, 114 b, 114 c, 114 d, 114 e and 114 f located inthe annulus section 110 of the stent. That is, the edge 122 ispositioned in substantial alignment with struts 114 a, 114 b, 114 c, 114d, 114 e, and 114 f. Struts 114 a, 114 b, and 114 c may be connected toone another in substantially end-to-end fashion diagonally along threecells 112, beginning with an end of the strut 114 a connected to acommissure point 116 and ending with an end of strut 114 c connected toan end of strut 114 d. Struts 114 c and 114 d are part of the same cell112 and may collectively define a substantially right angle betweenthem. Struts 114 d, 114 e, and 114 f may be connected to one another insubstantially end-to-end fashion diagonally along three cells 112,beginning with an end of the strut 114 f connected to a commissure point116 and ending with the connection between an end of strut 114 c and anend of strut 114 d.

As discussed above, the leaflets 108 may be attached directly to andsupported by the struts 114 a, 114 b, 114 c, 114 d, 114 e, and 114 f,such as by suturing. In such event, the cuff 106 may perform little orno supportive function for the leaflets 108. Hence, the cuff 106 is notsubjected to high stresses and is therefore less likely to fail duringuse. In light of this, the thickness of the cuff may be reduced.Reducing the thickness of the cuff 106 results in a decrease in thevolume of the valve assembly 104 in the collapsed condition. Thisdecreased volume is desirable as it enables the prosthetic heart valve100 to be implanted in a patient using a delivery device that is smallerthan conventional delivery devices. In addition, since the materialforming the stent struts 114 is stronger than the material forming thecuff 106, the stent struts 114 may perform the supportive function forthe leaflets 108 better than the cuff 106.

The volume of the valve assembly 104 may be further reduced by havingthe cuff 106 cover only a portion of the surface of annulus section 110.With continued reference to FIG. 1, the first or proximal end 118 of thecuff 106 may substantially follow the contour of the first or proximalend 119 of the stent 102. As such, the proximal end of the cuff 106 mayhave a generally sinusoidal or zigzag shape. This eliminates any freeedge of the cuff 106, which otherwise might extend directly between thecusps of the cells 112 at the proximal end 119 of the stent 102, andenables the entire length of the proximal end 118 of the cuff 106 to besecured to the stent 102. The second or distal end 120 of the cuff 106,on the other hand, may be disposed substantially along at least somestruts 114, but not necessarily the struts in a single annular row ofcells 112. More particularly, the distal end 120 of the cuff 106 mayfollow the stent struts 114 up to the commissure points 116, such thatthe cuff covers all of the cells 112 in the bottom annular row 113 ofcells and in a second annular row 115 of cells located between thecommissure points and the proximal end 119 of the stent 102, but coversa lesser area of cells in the annular regions between the commissurepoints. In other words, the distal end 120 of the cuff 106 may bedisposed substantially along struts 114 a, 114 b, 114 e, 114 f, 114 gand 114 h, as shown in FIG. 1. Strut 114 g may be connected at one endto strut 114 h, and at the other end to the intersection of struts 114 band 114 c. Strut 114 h may be connected at one end to strut 114 g, andat the other end to the intersection of struts 114 d and 114 e. Struts114 c, 114 d, 114 g, and 114 h collectively form a single cell 112.

As a result of the foregoing configuration, all of the cells 112 in thebottom annular row 113 of cells may be entirely covered by the cuff 106.The cuff 106 may also entirely cover those cells 112 in the secondannular row 115 that are located directly below the commissure points116. All of the other cells 112 in the stent 102 may be open or notcovered by the cuff 106. Hence, there may be no cells 112 which are onlypartially covered by the cuff 106.

Since the edges of the valve leaflets 108 extend up to the secondannular row 115 of cells 112 only in the regions of the commissurepoints 116, there is little to no likelihood of leakage in the area ofthe cells between the commissure points in the second annular row ofcells, and therefore no need for the cuff 106 to cover this area. Thisreduction in the area of the cuff 106, both at the proximal end 118 andat the distal end 120 thereof, reduces the amount of material in thevalve assembly 104, thereby enabling the prosthetic valve 100 to achievea smaller cross-section in the collapsed condition.

In operation, the embodiments of the prosthetic heart valve describedabove may be used to replace a native heart valve, such as the aorticvalve, a surgical heart valve or a heart valve that has undergone asurgical procedure. The prosthetic heart valve may be delivered to thedesired site (e.g., near a native aortic annulus) using any suitabledelivery device, including the delivery devices described in detailbelow. During delivery, the prosthetic heart valve is disposed insidethe delivery device in the collapsed condition. The delivery device maybe introduced into a patient using a transfemoral, transapical ortransseptal approach. Once the delivery device has reached the targetsite, the user may deploy any of the prosthetic heart valves describedabove. Upon deployment, the prosthetic heart valve expands into secureengagement within the native aortic annulus. When the prosthetic heartvalve is properly positioned inside the heart, it works as a one-wayvalve, allowing blood to flow in one direction and preventing blood fromflowing in the opposite direction.

In a prosthetic heart valve, the valve assembly may be spaced from thedistal or aortic end of the stent by a distance that enables deploymentof the heart valve by an amount sufficient for the valve leaflets of theprosthetic valve to operate as intended, while the distal end of thestent remains captured by the delivery device. More particularly, aswill be explained further below, the annulus end of the prosthetic heartvalve may be deployed first, while the aortic end of the prostheticheart valve remains at least partially covered by the distal sheath ofthe delivery device. The annulus portion of the prosthetic heart valvemay be deployed so that the entirety of the valve leaflets, up to andincluding the commissures, is deployed and fully operational. Bydeploying the prosthetic heart valve in this manner, the user candetermine whether the valve leaflets are properly positioned relative tothe native valve annulus, and whether the valve is functioning properly.If the user determines that the positioning and operation of the valveare acceptable, the remainder of the valve may be deployed. However, ifit is determined that the leaflet position is improper or that the valveis not functioning properly, the user may resheath the valve and eitherreposition it for redeployment, or remove it entirely from the patient.This can be particularly important in very high risk patients who wouldtypically be recipients of these types of valves, because of the natureof their condition and the impact that may have on the shape and/orcondition of the native valve and valve annulus.

The features of this aspect of the present invention will be describedin connection with the prosthetic heart valve 200 shown in FIG. 2. Itwill also be noted that while the inventions herein described arepredominately discussed in terms of a tricuspid valve and a stent havinga shape as illustrated in FIG. 2, the valve could be a bicuspid valve,such as the mitral valve, and the stent could have different shapes,such as a flared or conical annulus section, a less-bulbous aorticsection, and the like, and a differently shaped transition section.

Prosthetic heart valve 200 includes an expandable stent 202 which may beformed from the same materials as each of the stents described above,and in particular, from those of the described materials that arecapable of self-expansion. Stent 202 extends from a proximal or annulusend 230 to a distal or aortic end 232, and includes an annulus section240 adjacent the proximal end, and an aortic section 242 adjacent thedistal end. The annulus section 240 has a relatively small cross-sectionin the expanded condition, while the aortic section 242 has a relativelylarge cross-section in the expanded condition. Preferably, annulussection 240 is in the form of a cylinder having a substantially constantdiameter along its length. A transition section 241 may taper outwardlyfrom the annulus section 240 to the aortic section 242. Each of thesections of the stent 202 includes a plurality of cells 212 connected toone another in one or more annular rows around the stent. For example,as shown in FIG. 2, the annulus section 240 may have two annular rows ofcomplete cells 212 and the aortic section 242 and transition section 241may each have one or more annular rows of partial cells 212. The cells212 in the aortic section 242 may be larger than the cells 212 in theannulus section 240. The larger cells in the aortic section 242 betterenable the prosthetic valve 200 to be positioned without the stentstructure interfering with blood flow to the coronary arteries.

Stent 202 may include one or more retaining elements 218 at the distalend 232 thereof, the retaining elements being sized and shaped tocooperate with female retaining structures provided on the deploymentdevice. The engagement of retaining elements 218 with the femaleretaining structures on the deployment device helps maintain prostheticheart valve 200 in assembled relationship with the deployment device,minimizes longitudinal movement of the prosthetic heart valve relativeto the deployment device during unsheathing or resheathing procedures,and helps prevent rotation of the prosthetic heart valve relative to thedeployment device as the deployment device is advanced to the targetlocation and during deployment.

The stent 202 may also include a plurality of commissure points 216 forattaching the commissure between two adjacent leaflets to the stent. Ascan be seen in FIG. 2, the commissure points 216 may lie at theintersection of four cells 212, two of the cells being adjacent oneanother in the same annular row, and the other two cells being indifferent annular rows and lying in end-to-end relationship. Preferably,commissure points 216 are positioned entirely within annulus section 240or at the juncture of annulus section 240 and transition section 241.Commissure points 216 may include one or more eyelets which facilitatethe suturing of the leaflet commissure to the stent.

The prosthetic heart valve 200 includes a valve assembly 204 positionedin the annulus section 240. Valve assembly 204 may be secured to stent202 in the various manners described above. Valve assembly 204 includesa cuff 206 and a plurality of leaflets 208 which collectively functionas a one-way valve. FIG. 2 illustrates a prosthetic heart valve forreplacing a native tricuspid valve, such as the aortic valve.Accordingly, prosthetic heart valve 200 is shown in FIG. 2 with threeleaflets 208, as well as three commissure points 216. However, it willbe appreciated that the prosthetic heart valves according to this aspectof the invention may have a greater or lesser number of leaflets andcommissure points.

Although cuff 206 is shown in FIG. 2 as being disposed on the lumenalsurface of annulus section 240, it is contemplated that the cuff may bedisposed on the ablumenal surface of annulus section 240, or may coverall or part of either or both of the lumenal and ablumenal surfaces ofannulus section 240. Both the cuff 206 and the leaflets 208 may bewholly or partly formed of any suitable biological material or polymer,including those, such as PTFE, described above in connection withprosthetic heart valve 100.

As is shown in FIG. 2, in one embodiment the entirety of valve assembly204, including the leaflet commissures, is positioned in the annulussection 240 of stent 202. When opened, the leaflets may extend furtherinto the transition region or may be designed such that they remainsubstantially completely within the annulus region. That is,substantially the entirety of valve assembly 204 is positioned betweenthe proximal end 230 of stent 202 and the commissure points 216, andnone of the valve assembly 204 is positioned between commissure points216 and the distal end 232 of the stent.

Indeed, in some embodiments, the valve can be designed such that, uponpartial deployment, the commissure points are fully exposed, orientedgenerally parallel to the direction of blood flow, and at or near theiractual radially expanded position (but not necessarily their eventualposition relative to the annulus), such that the leaflets can operatesubstantially as they would when the valve is fully deployed, eventhough enough of the stent is still retained within the delivery deviceor sheath to permit resheathing.

In a preferred arrangement, the distance between commissure points 216and the distal end 232 of stent 202 will be about two-thirds of thelength of the stent from the proximal end 230 to the distal end. Thisstructural arrangement provides advantages in the deployment ofprosthetic valve 200 as will be discussed in more detail with referenceto FIGS. 3A and 3B. By having the entirety of valve assembly 204positioned within annulus section 240, and by having a sufficientdistance between commissure points 216 and the distal end 232 of stent202, the valve assembly and commissures will not impede blood flow intothe coronary arteries and will not interfere with access thereto duringcardiac intervention, such as angiography, annuloplasty or stentplacement.

Further, it is possible to partially deploy prosthetic valve 200 so thatthe valve assembly 204 thereof is able to fully function in its intendedposition in the native valve annulus, while a sufficient amount of theaortic section 242 is retained within the delivery device shouldresheathing become necessary. In other words, as will be explained inmore detail below, the user may withdraw the distal sheath of thedelivery device to gradually expose prosthetic valve 200, beginning atthe proximal end 230. Continued withdrawal of the distal sheath willexpose a greater extent of the prosthetic valve until the entire annulussection 240 and valve assembly 204 have been exposed. Upon exposure,these portions of the prosthetic valve will expand into engagement withthe native valve annulus, entrapping the native valves, except for asmall portion immediately adjacent the free end of the distal sheathwhich will be constrained by the distal sheath from fully expanding.

However, once the distal sheath has been withdrawn to expose asufficient portion of the aortic section 242, the annulus section 240will be able to fully expand and valve assembly 204 will be able tofunction in the same manner as if the entirety of prosthetic valve 200had been deployed. At this juncture, it will be possible for the user toascertain whether annulus section 240 and valve assembly 204 have beenproperly positioned relative to the native valve annulus, and whetherthe valve assembly is functioning properly.

If the position and operation of valve assembly 204 are acceptable, thedistal sheath may be withdrawn further to deploy the remainder ofprosthetic valve 200. On the other hand, if the positioning or operationof valve assembly 204 is unacceptable, the user may advance the distalsheath to resheath the prosthetic valve, reposition same and initiatethe deployment procedure anew. And if it is determined that the valve isnot functioning properly, it can be withdrawn from the patient and a newvalve introduced.

Stated another way, as shown in FIGS. 3A and 3B, the placement of theleaflets 208 within the stent 202 can affect the valve functioningduring partial deployment. FIG. 3A illustrates a valve assembly 204 withhigh placement, while FIG. 3B illustrates a valve assembly with lowplacement according to one embodiment of the present invention. As usedherein the phrase “high placement” of a valve assembly refers tolocating the valve assembly within the transition section 241 of thestent 202, or the portion of the annulus section 240 closest to thetransition section. The phrase “low placement” of a valve assemblyrefers to locating the valve assembly closer to the proximal end 230 ofthe stent 202 and entirely within the annulus section 240 thereof, suchthat the leaflets 208 are substantially disposed within the annulussection 208.

As seen in FIG. 3A, during partial deployment the annulus end of theheart valve 200 is unsheathed and allowed to expand. The distal end 232,including the aortic section 242, remains partially sheathed and coupledto the delivery device. Operation of the delivery device is describedbelow in more detail with reference to FIGS. 11-22. Turning back to FIG.3A, it will be appreciated that high placement of valve assembly 204will cause the valve assembly to not be fully deployed when heart valve200 is only partially deployed, thereby affecting leaflet function.Specifically, since the commissure points 216 are located closer to orwithin the transition section 241, they do not reach their fullyexpanded positions. As such, the leaflets 208 that are attached tocommissure points 216 remain partially closed. Because of the locationof the commissure points 216 and the leaflets 208, the valve assembly204 cannot be tested during partial deployment. Instead, the user mustunsheath a portion of the aortic section 242 as well, which may poseproblems if the valve assembly 204 is to be resheathed and redeployed.

In contrast to the prosthetic heart valve of FIG. 3A, the heart valve200 of FIG. 3B exhibits low placement of the valve assembly 204 withinthe annulus section 240. Low placement of the valve assembly 204 enablesthe valve assembly to fully deploy when heart valve 200 is onlypartially deployed. As such, commissure points 216 and the leaflets 208attached to same reach their fully expanded and open positions and areable to function near normally, enabling a better assessment of thevalve's functioning and final placement within the actual anatomy. Thus,if it appears that the valve needs to be moved, the heart valve 200 maybe easily resheathed and repositioned. This concept is beneficial whendealing with less than ideal anatomical configurations as will bediscussed below with reference to FIGS. 5-9.

The shape of the stent 202 during partial deployment will also affectthe valve 204. If the stent shape is such that, while still partiallyretained by the sheath, it cannot open sufficiently to allow operationof the valve, it may not be possible to fully assess the operation ofthe valve in its intended placement position. Moreover, the height ofthe valve commissures 216 relative to the proximal end 230 of the valvewill affect the valve function. The lower the commissures 216, meaningthe closer to the proximal end 230, the more they will expand outwardlyand the valve leaflets will be able to open during partial deployment,creating a flow passageway through the leaflets which approaches that ofa fully deployed valve. The relationship of stent shape, commissureheight and valve location to flow passageway will be more fullydiscussed below with reference to FIGS. 4A and 4B.

FIGS. 4A and 4B illustrate a publicly known prosthetic heart valveavailable from Medtronic/CoreValve and a prosthetic heart valve 200 inaccordance with one embodiment of the present invention, respectively.Prosthetic heart valve 200 shown in FIG. 4B is substantially the same asthe prosthetic heart valve 200 shown in FIG. 2 and described above, butis repeated here to show a side-by-side comparison with the prostheticheart valve of FIG. 4A. See also United States Patent ApplicationPublication No. 2006/0259136 to Nguyen et al. and, in particular, FIG. 6thereof. The greater the distance between the valve assembly and thedistal end of the stent (the end of the stent to be disposed in theaorta or aortic sinus, furthest from the heart), the greater the chancethe valve will open and operate in a substantially normal fashion duringpartial deployment. The greater the distance the free end of the sheathis from the valve assembly during partial deployment, the more the stent202 can expand to a size and shape conducive for valve operation. Thus,the further the valve assembly 204 can be positioned from the free endof the delivery sheath during partial deployment, the better the flowthrough the valve.

The CoreValve device, as shown in FIG. 4A hereof and FIG. 6 of theaforementioned patent publication, has commissure supports that extendup into the transition or sinus region of the device. Therefore, it ispossible that part of the valve assembly itself will still be containedwithin the delivery sheath during partial deployment of approximatelytwo-thirds of the overall length of the valve. Even if that is not thecase, it is believed that the sheath will exert sufficient influence onthe stent and, with it, the valve assembly, to prevent the valve fromfunctioning properly unless more fully deployed.

As shown in FIG. 4B, the prosthetic valve 200 in accordance with thepresent invention contains a valve assembly 204 disposed more completelywithin the annulus section 240. Thus, if the same approximatelytwo-thirds of the length of the valve is exposed for partial deployment,the distance of the valve assembly 204 from the free end of the deliverysheath, coupled with the positioning of the valve assembly and thecommissure points 216 in the annulus section 240, allows for functionaloperation of the valve to be observed even during partial deployment.

Specifically, as illustrated in FIG. 4B, the placement of the valveassembly 204 in the annulus section of prosthetic valve devices inaccordance with the invention may provide additional benefits. In FIGS.4A and 4B, the annulus between the left ventricle and the aortic sinusof the native valve is represented by the line labeled “X”. The valve inFIG. 4A includes leaflets, represented by the dashed line labeled “L”,disposed a significant distance from the proximal or inlet end of thevalve. The leaflets L are attached near the upper edge Y of a cuffpositioned on the lumenal surface of the valve stent. The commissuresupports for the valve leaflets are attached relatively higher in thetransition region of the stent. The portion of the valve to be implantedin the native valve annulus, shown between dashed lines Y and Y′, iswide. But, if seated high (i.e., with dashed line Y′ relatively close tonative valve annulus X), the commissure supports could interfere withaccess to the coronary arteries. See FIG. 6 of United States PatentPublication No. 2006/0259136. If seated lower such that the valveleaflets are closer to the location of the native leaflets (i.e., withdashed line Y relatively close to native valve annulus X), the valvewill protrude into the left ventricle and could interfere with theoperation of the mitral valve or otherwise interfere with proper cardiacfunctioning. By comparison, in the embodiment of the inventionillustrated in FIG. 4B, the leaflets 208 are attached within the valveassembly 204 and the commissure points 216 are located in the annulussection 240 such that, when implanted, the prosthetic valve will neitherblock the coronary arteries nor protrude into the left ventricle in away that will cause an impediment.

Stated differently, the prosthetic valve in FIG. 4A may be described ashaving three portions between the proximal and distal ends: an annulusportion A, an intermediate portion B and an aortic portion C. Theannulus portion A extends from the proximal end of the valve to thepoint of attachment between the stent and the leaflets L. The secondportion B extends from the point of attachment between the stent and theleaflets L to the distalmost end of the commissure points. The aorticportion C extends from the distalmost end of the commissure points tothe distal end of the valve. As seen in FIG. 4A, the commissure pointsare located about one-third of the overall length of the valve from thedistal end, and the intermediate portion B containing the valve leafletsL is disposed about halfway between the valve's proximal and distalends. In contrast, the valve 200 of FIG. 4B includes a portion B thatextends from the commissure points 216 to the distal end 232 of thevalve with the commissure points being positioned about two-thirds ofthe overall length of the valve from the distal end. Moreover, as seenin FIG. 4B, the valve leaflets 208 are disposed substantially in theannulus section 240, which occupies about one-third of the overalllength of the valve farthest from the distal end 232.

As discussed above, the positioning of the valve assembly 204,commissure points 216 and leaflets 208 within the stent 202 affects theeffectiveness of the valve during partial deployment. The precedingembodiments allow for better assessment of the functioning of the valvebefore full deployment. The concepts discussed above with regard to thepositioning of the valve assembly 204, the commissure points 216 and theleaflets 208 within stent 202 provide additional improvements incoaptation of the leaflets 208.

In certain procedures, collapsible valves may be implanted in a nativevalve annulus without first resecting the native valve leaflets. Thecollapsible valves may have critical clinical issues because of thenature of the stenotic leaflets that are left in place. Additionally,patients with uneven calcification, bi-cuspid disease, and/or valveinsufficiency could not be treated well, if at all, with the currentcollapsible designs.

The reliance on evenly calcified leaflets could lead to several problemssuch as: (1) perivalvular leakage (PV leak), (2) valve migration, (3)mitral valve impingement, (4) conduction system disruption, (5) coronaryblockage, etc., all of which can have severely adverse clinicaloutcomes. To reduce these adverse events, the optimal valve would sealand anchor adequately without the need for excessive radial force,protrusion into the left ventricular outflow tract (LVOT), etc., thatcould harm nearby anatomy and physiology.

One potential solution is a valve that could be partially deployed toassess the above-mentioned issues before full deployment. This hasalready been discussed. Another potential solution, which can beemployed alone or with the ability to partially deploy, is the use of adesign which provides for suitable coaptation even in less than idealsettings. FIGS. 5 and 6 illustrate such a valve. The figures show an endview of the prosthetic valve 200 of FIG. 2 as seen from the downstreamside of the valve assembly 204, e.g., looking from the aorta or aorticsinus toward the heart and the native valve annulus. See also FIGS. 7Aand 7B, which provide a similar view of an embodiment of a valve 200.FIGS. 7C and 7D provide an end view of the valve 200 of FIGS. 7A and 7Bas seen from the upstream direction, e.g., looking from the leftventrical toward the aorta. FIGS. 7C and 7D illustrate, in particular,the annulus section of stent 202 and the valve assembly 204, includingthe cuff 206, from that perspective.

The valve assembly 204 includes valve leaflets 208 a, 208 b, and 208 cattached to commissure points 216 a, 216 b, and 216 c. The valveleaflets 208 a-c are attached to the stent 202 in any of theconfigurations previously described. At least one edge of each leaflet208 is sutured to the stent 202 and to two of the three commissurepoints 216, leaving at least one edge free to move in response to thepumping of blood. As the blood pressure in the left ventricle increases,the free edges of the leaflets move away from one another to allow bloodto flow from the left ventricle to the aorta, following which the freeedges move toward one another and coapt to prevent blood from flowingback from the aorta into the left ventricle.

It will be understood that the coaptation of “the free edges” of thevalve leaflets does not necessarily mean that the actual edges meet perse. Indeed, the leaflets are preferably sized, shaped, and attached suchthat a suitable “belly” contour is formed. And the leaflets should eachinclude a portion extending from the free edge toward the annulus(referred to herein as a “coaptation section”) that may engage thecoaptation sections of the other leaflets such that there will be asurface area of contact between the leaflets rather than edge-to-edgecontact. This surface area of contact is important so that, when in aclosed or “coapted” condition, the leaflets cooperate to substantiallyprevent backflow or regurgitation of blood through the valve. Theseareas of actual contact between the coaptation sections of adjacentleaflets are referred to herein as the coaptation junctions of theleaflets and are illustrated in FIG. 5 at 211 a, 211 b, and 211 c. Thecoaptation section of each leaflet may range in size as a particularvalve design demands, but generally will be sufficient to provide sometolerance or ability to form a coaptation junction even if the shape ofthe valve is distorted during placement, as illustrated in FIG. 6.

As shown previously in FIG. 2, the annulus section 240 of prostheticvalve 200 has a generally regular cylindrical shape by which is meantthat the structure has a generally circular cross-section with asubstantially constant diameter along its length. When placed in theannulus of a native heart valve, such as, for example, the tricuspidaortic valve, and expanded, a substantially fluid-tight fit shouldresult. However, the native valve annulus may not be circular, and, infact, may vary from patient to patient, as may the shape of the aorticsinus or aorta, the angle of the junction between the valve annulus andthe aortic sinus, and other local anatomical features. When prostheticvalve 200 is deployed and expanded, it must accommodate these anatomicalvariations in order to function properly. This may result in adistortion in the shape of stent 202 and/or valve assembly 204, and therepositioning of leaflets 208 a, 208 b, and 208 c relative to oneanother, which can affect the coaptation junctions 211 a, 211 b, and 211c.

As the stent of a collapsible prosthetic heart valve distorts duringimplantation, during beating of the heart, or because of irregularitiesin the patient's anatomy or the condition of the native valve, suchdistortion may be translated to the valve assembly, such that not all ofthe valve leaflets meet to form effective coaptation junctions. This canresult in leakage or regurgitation and other inefficiencies which canreduce cardiac performance. Moreover, if the prosthetic valve is notplaced optimally and the valve leaflets are not coapting as intended,other long term effects, such as uneven wear of the individual leaflets,can be postulated.

Prosthetic valves in accordance with certain aspects of the presentinvention, however, can function properly notwithstanding the distortionof the stent 202 and/or valve assembly 204. For example, as shown inFIG. 6, valve leaflets 208 a, 208 b, and 208 c fully coapt despite thedistortion of the annulus section 240 (hidden behind the valve leafletsin this figure) into a more elliptical configuration. As will beappreciated, the distortion of the annulus section 240 affects therelative positions of commissure points 216 a-c, as well as thepositions of leaflets 208 a-c relative to one another. The ability ofthe valve leaflets 208 a-c to fully coapt despite this distortionenables prosthetic valve 200 to function in the manner intended.

Although FIG. 6 illustrates a situation in which annulus section 240 hasbeen distorted such that the major axis of the resulting ellipse orirregular shape is substantially parallel to coaptation junction 211 b,that need not be the case. Depending on the shape of the native valveannulus and the orientation in which the prosthetic valve is deployed,the annulus section 240 and/or the valve assembly 204 may be distortedsuch that the major axis of the resulting shape is oriented in anyradial direction relative to the longitudinal axis of the prostheticvalve. As can be appreciated from FIGS. 7A-D, regardless of thedirection of distortion, valve leaflets 208 a-c are able to fully coaptand prosthetic valve 200 is able to function properly. The valveleaflets 208 a-c are capable of effective engagement along coaptationjunctions 211 a-c in any anatomical configuration of the native valveannulus, such as circular, elliptical, ovoid or any other curvedconfigurations.

A comparison between FIGS. 8A-B and FIGS. 8C-D illustrates thedifference between inadequate coaptation of a conventional prostheticvalve and superior coaptation of a prosthetic valve according to oneembodiment of the present invention. As will be appreciated from FIGS.8A and 8B, the leaflets 208 of a conventional device are incapable ofcomplete coaptation when disposed in a native valve annulus with anelliptical, ovoid or otherwise non-circular configuration. Specifically,a shallow belly contour 282 as seen in FIG. 8B creates a gap 238 betweenthe leaflets 208. The end view seen in FIG. 8A illustrates inadequatecoaptation which may lead to leakage and regurgitation as discussedabove.

By way of comparison, the leaflets 208 seen in FIGS. 8C and 8D providesuperior coaptation. Specifically, the leaflets 208 of FIGS. 8C and 8Dare slightly elongated and include a deeper belly contour 282, forming acoaptation section 222. As used herein the term “belly contour” refersto the curvature of the leaflets 208. The leaflets 208 according to oneembodiment of the present invention include a belly contour that iscurved concavely toward the distal end of the stent. The curvature ofthe leaflets 208 may affect the coaptation of the leaflets. In someembodiments, a smaller radius of curvature is preferred. As seen in theend view of FIG. 8C, the leaflets 208 merge smoothly and no gap isformed between the leaflets in the closed position. The deeper bellycontour 282 and the leaflets 208 having coaptation sections 222 allowthe leaflets to adequately coapt regardless of the shape orconfiguration of the native valve annulus. In at least some embodiments,the leaflets form a coaptation section 222 that is substantiallyparallel to the longitudinal axis of the valve. The leaflets 208 may beconfigured such that a steep belly contour 282 is formed. Though thecurvature of the leaflets 208 may vary, a steeper belly contour 282 maybe preferable to a shallow belly contour. The curvature of the leaflets208 in the closed position may be modeled by a mathematical function(e.g., exponential or polynomial functions).

FIGS. 9A-9D illustrate the difference between inadequate coaptation of aconventional prosthetic valve and superior coaptation of a prostheticvalve according to a second embodiment of the present invention. As seenin FIGS. 9A and 9B, the leaflets 208 of the valve do not include ashallow belly contour as seen in FIG. 8B. Instead, the leaflets of FIGS.9A and 9B are flat. Due to an elongated axis or irregular shape (e.g.,the native valve annulus being elliptical), the leaflets 208 in FIG. 9Bdo not fully contact or merge. The result, as seen in FIG. 9A, is a gap238 between the leaflets 208 similar to that formed in the valve of FIG.8A. In contrast, the embodiment shown in FIGS. 9C and 9D includes a flatbelly (e.g., none of the belly contour seen in FIGS. 8C-D), and acoaptation section 222 that provides a level of tolerance in case of anelongated axis or irregular shape. The leaflets 208 form a first flatbelly section 292 angled toward the center of the valve and a secondcoaptation section 222 that is substantially parallel to thelongitudinal axis of the valve. The leaflet coaptation section 222compensates for an elongated axis and provides adequate coaptationbetween the leaflets 208.

The coaptation section 222 as shown in FIG. 9D may range from about 1 mmto about 5 mm in length in a direction from the free edge of the leaflet208 toward the stent 202. Preferably, the coaptation section will beabout 1.5 mm to about 4 mm in length, and more specifically about 2 mmto about 3.5 mm in length. As discussed above, the coaptation section222 may be configured such that when the leaflets 208 are broughttogether in a closed state of the valve, the coaptation section 222forms a segment that is substantially parallel to the longitudinal axisof the valve. In at least some embodiments, the coaptation section 222occupies about 10% to about 30% of the total length of each leaflet 208.

Without being bound by any particular theory, it is believed thatseveral factors and unique design attributes of prosthetic valve 200contribute to its adaptability to variations in the natural anatomy ofthe patient as exemplified in FIG. 6. The commissure points 216 a, 216b, and 216 c are not elongated posts or bars and are integrated into thesuperstructure of stent 202 such that they, individually andcollectively, do not negatively impact the flexibility of the stent.Because the commissure points 216 a-c and the valve leaflets 208 a-c areboth disposed within, or substantially within, the annulus section 240,anatomical irregularities in the aorta and/or the aortic sinus will haverelatively less impact on the coaptation junctions 211 a-c than if thesevalve components were positioned in or extended into the transitionsection 241 or the aortic section 242. Furthermore, because thecross-section of the native valve annulus is typically less than thecross-section of the aortic sinus, the range of variations in the nativevalve annulus to which the prosthetic valve must adapt will ordinarilybe less than in the aortic sinus.

Moreover, as the commissure points 216 a-c and valve leaflets 208 a-care disposed within or substantially within the annulus section 240, thecoaptation junctions 211 a-c will be influenced little, if at all, byany irregularities in the junction between the native valve annulus andthe aortic sinus (such as where the aortic sinus is skewed at an angleto the native valve annulus).

In addition, the location of the commissure points 216 a-c in theannulus section 240, or immediately adjacent thereto, and the attachmentof the valve assembly 204 within that section, as illustrated in FIG. 2,helps restrict the degree of movement of one leaflet relative toanother. If the commissure points 216 a-c were disposed higher, such asin the transition section 241 or the aortic section 242 of theprosthetic valve, then any deformation of the annulus section 240, whichwould result in an overall deformation of the stent 202, could cause alarger relative movement of, for example, the commissures. This couldoverwhelm any reasonable overlap that may be present in the coaptationjunctions 211 a-c of the valve leaflets 208, reducing their likelihoodof coaptation. Thus, the change in shape of the stent would be magnifiedand this would further magnify the effect on the relative positions ofthe valve leaflets 208 a-c and their coaptation junctions 211 a-c. Bykeeping the valve assembly substantially within the annulus section 240,these magnifying influences can be suppressed.

In addition to coaptation issues, anatomical and positionalirregularities can create issues with respect to the proper functioningand wear of the prosthetic valve. Another aspect of the invention isachieving a better functioning valve in these various shapes, such aselliptical, round, ovoid, irregular, etc.

As illustrated in FIGS. 8A-D and 9A-D, the valve shape, size andconfiguration are also important in ensuring that the valve functionsproperly even when implanted in a less than ideal geometry. The amountof leaflet material provided should be sufficient to allow for thecreation of a “leaflet belly” having a parabolic-like contour.Sufficient leaflet material must be used to ensure that there is asufficient length of free edge between adjacent commissure points 216,and also to provide a sufficient belly contour 282 such that thecoaptation junctions of the leaflet can properly form a coaptationsection 222, even when the relative alignment of the leaflets isdisturbed from an ideal alignment. Too shallow a belly contour 282 maylead to a central gap 238, a break in the coaptation junction betweenadjacent leaflets and/or put too much load or stress on the leaflet atthe point of attachment to the commissure point.

Yet, the coaptation section 222 should not be so large so as to producea free edge that curls over, interferes with coaptation, or extends toofar into the transition section of the stent. For example, FIG. 10illustrates a side elevational view of a prosthetic valve 200 havingleaflets 208 with poor coaptation and excess slack. The leaflets of FIG.10 angle toward the center of the valve and coapt, but come apart attheir free ends, outwardly curling over the coaptation section 222. Sucha configuration may interfere with coaptation or negatively affect flowthrough the valve. Thus, it will be understood that the shape andconfiguration of the leaflets 208 and the coaptation sections 222 oughtto be within a favorable range as described above.

A transfemoral or transapical delivery device may be used to partiallydeploy the prosthetic heart valve such that an assessment may be maderegarding flow through the valve and adequacy of coaptation. If, afterthe annulus section is unsheathed and the valve is tested, it is foundthat the valve needs to be repositioned, the annulus section may beresheathed and the valve redeployed as necessary.

Turning now to FIGS. 11-14, an exemplary transfemoral delivery device1010 for a collapsible prosthetic heart valve (or other types ofself-expanding collapsible stents) has a catheter assembly 1016 fordelivering the heart valve to and deploying the heart valve at a targetlocation, and an operating handle 1020 for controlling deployment of thevalve from the catheter assembly. The delivery device 1010 extends froma proximal end 1012 to a distal tip 1014. The catheter assembly 1016 isadapted to receive a collapsible prosthetic heart valve (not shown) in acompartment 1023 defined around an inner shaft 1026 and covered by adistal sheath 1024.

The inner shaft 1026 extends through the operating handle 1020 to thedistal tip 1014 of the delivery device, and includes a retainer 1025affixed thereto at a spaced distance from distal tip 1014 and adapted tohold a collapsible prosthetic valve in the compartment 1023.

The distal sheath 1024 surrounds the inner shaft 1026 and is slidablerelative to the inner shaft such that it can selectively cover oruncover the compartment 1023. The distal sheath 1024 is affixed at itsproximal end to an outer shaft 1022, the proximal end of which isconnected to the operating handle 1020 in a manner to be described. Thedistal end 1027 of the distal sheath 1024 abuts the distal tip 1014 whenthe distal sheath is fully covering the compartment 1023, and is spacedapart from the distal tip 1014 when the compartment 1023 is at leastpartially uncovered.

The operating handle 1020 is adapted to control deployment of aprosthetic valve located in the compartment 1023 by permitting a user toselectively slide the outer shaft 1022 proximally or distally relativeto the inner shaft 1026, thereby respectively uncovering or covering thecompartment with the distal sheath 1024. The proximal end of the innershaft 1026 is affixed to an outer frame 1030 of the operating handle1020, and the proximal end of the outer shaft 1022 is affixed to acarriage assembly 1040 of the operating handle that is slidable along alongitudinal axis of the frame, such that a user can selectively slidethe outer shaft relative to the inner shaft by sliding the carriageassembly relative to the frame.

A hemostasis valve 1028 (shown, for example, in FIG. 14) includes aninternal gasket adapted to create a seal between the inner shaft 1026and the proximal end of the outer shaft 1022. A gasket adjustment wheel1042 in the carriage assembly 1040 is adapted to adjust the strength ofthis seal. For example, the gasket inside the hemostasis valve 1028 maybe in the shape of an O-ring located around the inner shaft 1026. Whenthe strength of the seal is insufficient, there may be a gap between theO-ring and the outer surface of the inner shaft 1026. To eliminate thisgap, a user can turn the gasket adjustment wheel 1042 to place acompressive force on the O-ring in the longitudinal direction of theinner shaft 1026, thereby compressing the O-ring longitudinally andexpanding the O-ring radially. The radially expanded O-ring can fill thegap between the O-ring and the outer surface of the inner shaft 1026,thereby creating a liquid-proof seal therebetween.

The frame 1030 includes a pair of side rails 1031 joined at the proximalend 1012 by a proximal end member 1032 and joined at the distal end by adistal end member 1033. Collectively, the side rails 1031, the endmember 1032, and the end member 1033 define an elongated space 1034 inthe frame 1030 in which the carriage assembly 1040 may travel. Theelongated space 1034 preferably permits the carriage assembly 1040 totravel a distance that is at least as long as the anticipated length ofthe prosthetic valve to be delivered (e.g., at least about 50 mm), suchthat the distal sheath 1024 can be fully retracted off of the prostheticvalve. An enlarged bore 1035 in the end member 1033 is sized to freelyand slidingly receive a threaded rod 1036 (shown in FIG. 13) extendingfrom the distal end of the carriage assembly 1040, as described below.The enlarged bore 1035 has a smooth interior surface and has an innerdiameter slightly larger than the outer diameter of the threaded rod1036 (a longitudinal cross-section of the threaded rod positioned insideof the enlarged bore is shown in FIG. 15).

The carriage assembly 1040 includes a main body 1041 and the threadedrod 1036 extending distally therefrom along the longitudinal axis of theouter frame 1030. The threaded rod 1036 preferably is longer than theanticipated maximum travel distance of the carriage assembly 1040 withinthe elongated space 1034 (e.g., at least about 50 mm), such that thethreaded rod does not fully withdraw from the enlarged bore 1035 duringdeployment of the prosthetic valve.

A deployment actuator 1021 is threadedly engaged with the threaded rod1036. The deployment actuator is positioned in abutting relationshipwith the end member 1033 of the frame 1030 so that rotation of theactuator in one direction (either clockwise or counterclockwisedepending on the orientation of the threads on the threaded rod 1036)causes the threaded rod and the carriage assembly 1040 to moveproximally within the elongated space 1034. Rotation of the deploymentactuator 1021 in the opposite direction, however, does not causetranslational movement of carriage assembly 1040, but rather simplycauses the deployment actuator to threadedly advance on the threaded rod1036 as it moves away from the end member 1033 of the frame 1030.Although the movement of the deployment actuator 1021 away from the endmember 1033 of the frame 1030 enables the carriage assembly 1040 to movedistally until the deployment actuator again contacts the distal endmember 1033 of the frame, such movement is not easily controllable, butrather is subject to the “touch and feel” of the user.

In a variant of the embodiment described above, the deployment actuator1021 may be longitudinally constrained relative to the frame 1030, forexample, by the engagement of an annular rib on the distal end of thedeployment actuator with an annular groove in the bore 1035 so that thedeployment actuator 1021 may rotate in either direction without movingaway from the distal end member 1033 of the frame. Rather than anannular rib and an annular groove, any mechanism may be used forlongitudinally fixing the deployment actuator 1021 relative to thedistal end 1033 of the frame 1030 so as to permit rotation of thedeployment actuator in both directions without translation of samewithin the space 1034. Such an arrangement would provide a user with theability to carefully control movement of the carriage assembly 1040 bothproximally within the space 1034 during a valve deployment operation,and distally within the space 1034 during a resheathing operation, asdescribed more fully below.

Referring now to FIGS. 15-17, the carriage assembly 1040 includes adeployment lock 1043 adapted to prevent any movement of the carriageassembly within the frame 1030, thereby preventing a user fromaccidentally initiating deployment of a prosthetic valve. The deploymentlock 1043 includes a control member 1049 that is longitudinally slidablein a slot 1045 between a distal position (shown in FIG. 15) and aproximal position (not shown). The control member 1049 includes a camslot 1053 disposed in its upper surface, the distal end of the cam slotbeing spaced farther from the adjacent side rail 1031 than the proximalend thereof. A locking member 1051 includes a downwardly projecting pin1056 which travels in the cam slot 1053. The locking member 1051 alsohas a laterally projecting pin 1055 which extends through an aperture1047 in the main body 1041. With the carriage assembly 1040 in itsinitial position, the aperture 1047 is aligned with a recess 1037 in theside rail 1031 of the frame 1030. When the control member 1049 is in itsdistalmost or locked position (shown in FIG. 15), the pin 1056 of thelocking member 1051 will be at the proximal end of the cam slot 1053,such that the pin 1055 will extend through the aperture 1047 and intothe recess 1037, thus locking the carriage assembly 1040 from anylongitudinal movement relative to the frame 1030. Movement of thecontrol member 1049 proximally to an unlocked position causes the pin1056 of the locking member 1051 to move toward the distal end of the camslot 1053, thereby moving the locking member laterally inward until thepin 1055 is no longer engaged in the recess 1037. This action thus freesthe carriage assembly 1040 for longitudinal movement relative to theframe 1030.

The carriage assembly 1040 also includes a resheathing lock 1044 adaptedto limit the longitudinal movement of the carriage assembly within theouter frame 1030, thereby preventing a user from accidentally completingthe deployment of a prosthetic valve. The resheathing lock 1044 includesa control member 1050 that is longitudinally slidable in a slot 1046between a distal position (shown in FIG. 15) and a proximal position(not shown). The control member 1050 includes a cam slot 1054 disposedin its upper surface, the distal end of the cam slot being spacedfarther from the adjacent side rail 1031 than the proximal end thereof.A locking member 1052 includes a downwardly projecting pin 1056 whichtravels in the cam slot 1054. The locking member 1052 also has alaterally projecting pin 1055 which extends through an aperture 1048 inthe main body 1041. With the carriage assembly 1040 in its initialposition, the aperture 1048 is aligned with the distal end 1038′ of alongitudinally extending slot 1038 in the side rail 1031 of the frame1030. When the control member 1050 is in its distalmost position (shownin FIG. 15), the pin 1056 of the locking member 1052 will be at theproximal end of the cam slot 1054, such that the pin 1055 will extendthrough the aperture 1048 and into the slot 1038. Such condition willenable the carriage assembly 1040 to move longitudinally within theframe 1030 between an initial position at which the pin 1055 contactsthe distal end 1038′ of the slot 1038 and a position at which the pin1055 contacts the proximal end 1038″ of the slot 1038. Movement of thecontrol member 1050 proximally causes the pin 1056 of the locking member1052 to move toward the distal end of the cam slot 1054, thereby movingthe locking member laterally inward until the pin 1055 is no longerengaged in the slot 1038. This action thus frees the carriage assembly1040 for further proximal movement relative to the frame 1030, therebypermitting full deployment of a prosthetic valve from the compartment1023 of catheter assembly 1016.

The slot 1038 has a length L1 between the distal end 1038′ and theproximal end 1038″ that is slightly greater than the initial distancethat the carriage assembly 1040 may travel while still permittingresheathing of the valve contained in the compartment 1023. Moreparticularly, the length L1 is equal to this initial travel distanceplus the diameter of the pin 1055. As a result, when the resheathinglock 1044 is in the locked position, the carriage assembly 1040 can moveproximally relative to the frame 1030 only by this amount.

The initial distance that the carriage assembly 1040 can travel beforebeing limited by the proximal end 1038″ of the slot 1038 may depend onthe structure of the particular prosthetic valve to be deployed.Preferably, the initial travel distance of the carriage assembly 1040 isabout 3 mm to about 5 mm less than the crimped valve length.Alternatively, the initial travel distance of the carriage assembly 1040may be about 40 mm to about 45 mm, which is about 80% to about 90% ofthe length of an exemplary 50 mm valve. In other arrangements, theinitial distance that the carriage assembly 1040 can travel and/or thelength of the slot 1038 can be determined as a percentage of the lengthof the prosthetic valve and/or of the compartment 1023, including, forexample, 50%, 60%, 70%, 75%, 85%, or 95%.

The operation of the delivery device 1010 to deploy a prosthetic valvewill now be described. To load the delivery device 1010 with acollapsible prosthetic valve, a user can retract the distal sheath 1024to expose the compartment 1023, place the valve around the inner shaft1026, couple the proximal end of the valve to the retainer 1025,compresses or crimp the valve, and slide the distal sheath back over thecompartment, which holds the valve in a compressed state. In thisstarting condition, the handle 1020 will be in an initial state with thecarriage assembly 1040 at its distalmost position within the frame 1030,the deployment lock 1043 in its locked position to prevent accidentaldeployment, and the resheathing lock 1044 in its locked position toprevent full deployment once the deployment lock 1043 has been unlocked.

To use the operating handle 1020 to deploy a prosthetic valve that hasbeen compressed and inserted in the compartment 1023 and covered by thedistal sheath 1024, a user will initially move the deployment lock 1043to its unlocked position, thereby freeing the carriage assembly 1040 forlongitudinal movement. The user can then rotate the deployment actuator1021, causing the carriage assembly 1040 to slide proximally within theelongated space 1034 in frame 1030. Because the distal sheath 1024 isaffixed to the outer shaft 1022, which in turn is affixed to thecarriage assembly 1040, and because the inner shaft 1026 is affixed tothe frame 1030, sliding the carriage assembly proximally relative to theframe will retract the distal sheath proximally from the compartment1023, thereby exposing and initiating deployment of the valve locatedtherein.

It will be appreciated that the user can initiate the deployment processwithout use of the deployment actuator 1021 by simply grasping thecarriage assembly 1040 and pulling same proximally within the frame1030. Such action requires significant pulling force in order toovercome the frictional forces acting on the outer shaft 1022 and thedistal sheath 1024. For that reason, the use of the deployment actuator1021 to retract the distal sheath 1024 is preferred since such useprovides the user with a mechanical advantage to overcome theaforementioned frictional forces, thereby providing the user with muchgreater control of the deployment process.

In any event, since the resheathing lock 1044 is in the locked position,movement of the carriage assembly 1040 proximally may continue onlyuntil the pin 1055 of the locking member 1052 contacts the proximal end1038″ of the slot 1038. At this point, the distal sheath 1024 will notbe fully withdrawn from the compartment 1023, and the prosthetic valvewill not be fully deployed.

When the deployment procedure has reached this juncture, the user canevaluate the position of the valve and determine whether the annulus endof the valve is properly aligned relative to the patient's aorticannulus. If repositioning is desired, the user may resheath the valve bysliding the carriage assembly 1040 distally within the frame 1030,thereby moving the distal sheath 1024 distally over the compartment 1023and the partially deployed valve and recollapsing the expanded part ofthe stent portion of the valve. This may be accomplished by rotating thedeployment actuator 1021 to advance it proximally on the threaded rod1036 and simply pushing the carriage assembly 1040 in the distaldirection or, in the variant embodiment in which the deployment actuator1021 is longitudinally fixed relative to the distal end member 1033 ofthe frame 1030, by rotating the deployment actuator in the directionopposite that used for deployment. Such rotation will cause the threadedrod 1036 to progress distally through the deployment actuator 1021 untilthe carriage assembly 1040 has reached the starting condition shown inFIG. 15. With the valve resheathed, the user can reposition the catheterassembly 1016 and commence the deployment procedure once again.

Once the valve has been properly positioned relative to the aorticannulus, the user may complete the deployment process. To do so, theuser slides the resheathing lock 1044 from the locked position to theunlocked position, thereby retracting the pin 1055 of locking member1052 so that the carriage assembly 1040 is free to continue its movementproximally within the frame 1030. The user can complete the deploymentof the valve by continuing to slide the carriage assembly 1040proximally, for example, by rotating the deployment actuator 1021. Whenthe valve has been unsheathed, the stent portion of the valveself-expands and disengages from the retainer 1025, thereby releasingthe valve from the catheter assembly 1016.

Referring now to FIG. 18, a portion of an operating handle 1020 a inaccordance with another embodiment of the invention is shown. Theoperating handle 1020 a is suitable for use with the catheter assembly1016 described above with reference to FIG. 11. The operating handle1020 a is similar to the operating handle 1020 described above, butdiffers in that it includes a second resheathing lock 1044 a in additionto the first resheathing lock 1044. Hence, the operating handle 1020 ais capable of limiting the proximal movement of the carriage assembly1040 a at two separate locations, rather than at a single location. Thecarriage assembly 1040 a is similar to the carriage assembly 1040 shownin FIGS. 11-15, except for the addition of the second resheathing lock1044 a.

The frame 1030 a of the operating handle 1020 a is similar to the frame1030 shown in FIGS. 11, 12, and 14-16, except that the side rail on theside opposite resheathing lock 1044 includes a second resheathing slot1038 a. The slot 1038 a has a length between its distal end 1038 a′ andits proximal end 1038 a″ that is slightly greater than an initialdistance that the carriage assembly 1040 a may travel to effect apartial deployment of the prosthetic valve. More particularly, thelength of the slot 1038 a is equal to this initial travel distance plusthe diameter of the pin 1055 a in the second resheathing lock 1044 a. Asa result, when the second resheathing lock 1044 a is in the lockedposition, the carriage assembly 1040 a can move proximally relative tothe frame 1030 a only by this amount. Preferably, this initial traveldistance of the carriage assembly 1040 a is about 25 mm, or about halfof the length of a conventional prosthetic aortic valve. In otherarrangements, this initial travel distance may be about 40% to about 60%of the length of a conventional prosthetic aortic valve.

The valve deployment process using the operating handle 1020 a issimilar to the deployment process described above in connection with theoperating handle 1020, except for the use of the second resheathing lock1044 a. Thus, to use the operating handle 1020 a to deploy a prostheticvalve from compartment 1023 of catheter assembly 1016, the user canfirst move the deployment lock 1043 to an unlocked position, therebyfreeing carriage assembly 1040 a for proximal movement relative to theframe 1030 a. With the deployment lock 1043 in the unlocked position,the user can rotate the deployment actuator 1021 to move the carriageassembly 1016 proximally until the lateral pin 1055 a of resheathinglock 1044 a contacts the proximal end 1038 a″ of the second resheathingslot 1038 a.

At this stage of deployment, while the second resheathing lock 1044 a isin the locked position, the user can decide to resheath and repositionthe valve. At about the halfway-unsheathed position, the valve may bepartially functioning, such that the user can assess the valve positionand decide whether to continue deployment or to resheath and repositionthe valve. If the position of the valve appears to be acceptable, theuser can continue to the next stage of deployment by moving the secondresheathing lock 1044 a to the unlocked position, freeing the carriageassembly 1040 a for further proximal movement within the frame 1030 a.

With the second resheathing lock 1044 a unlocked, the user can continueto rotate the deployment actuator 1021 to further move the carriageassembly 1040 a proximally. However, since the resheathing lock 1044 isin the locked position, the proximal movement of the carriage assembly1040 a may continue only until the pin 1055 of the locking member 1052contacts the proximal end 1038″ of the slot 1038. At this point, thedistal sheath 1024 will not be fully withdrawn from the compartment1023, and the prosthetic valve will still not be fully deployed. Onceagain, the user may evaluate the position of the valve and determinewhether repositioning is necessary. If repositioning is desired, theuser may resheath the valve by sliding the carriage assembly 1040 adistally within the frame 1030 a in the manner described above. On theother hand, if the valve position is acceptable, the user may unlock theresheathing lock 1044 and complete the deployment of the valve bycontinuing to slide the carriage assembly 1040 a proximally, such as byrotating the deployment actuator 1021.

Referring now to FIG. 19, an operating handle 1120 in accordance withanother embodiment of the invention is shown. The operating handle 1120is suitable for use with the catheter assembly 1016 described above withreference to FIG. 11. The operating handle 1120 is similar to theoperating handle 1020 described above with reference to FIGS. 11-17, butdiffers in the structure of the deployment lock and the resheathinglock, although these locks function in substantially the same way asdescribed above.

The operating handle 1120 includes a carriage assembly 1140 having aresheathing lock 1144 that controls the lateral retraction of a lockingpin 1155. The resheathing lock 1144 includes a cam member 1160 that isslidably mounted in an elongated slot 1146. The cam member 1160 has atapered surface 1161, such that when the cam member is slid proximallyin the slot 1146, the locking pin 1155 retracts in a lateral directionout of the slot 1138, thereby permitting the carriage assembly 1140 tocontinue proximally past the limit set by the proximal end of slot 1138and enabling the valve to be fully deployed.

Although the retraction mechanism for the locking pin 1155 is not shownin FIG. 19, when the resheathing lock 1144 is slid proximally, thelocking pin 1155 maintains contact with the tapered surface 1161 of theresheathing lock, thereby pulling the locking pin 1155 out of engagementwith the slot 1138. For example, a perpendicularly protruding portion ofthe locking pin 1155 may travel in a slot (similar to how the pin 1056travels in the cam slot 1054) that forces the locking pin 1155 tomaintain contact with the tapered surface of the resheathing lock 1144.Alternatively, the pin 1155 may be inwardly biased by a spring, suchthat the pin is pulled out of the slot 1138 by the spring as the cammember 1160 is slid proximally in the slot 1146. Other arrangements forretracting locking pin 1155 will be known to the skilled artisan and maybe used herewith.

Although a deployment locking mechanism is not shown in FIG. 19, adeployment lock similar in structure to the resheathing lock 1144 can beincluded that is capable of engaging and withdrawing a second lockingpin into and out of the recess 1137 located in the frame side railopposite the slot 1138.

Referring now to FIG. 20, an operating handle 1120 a in accordance withyet another embodiment of the invention is shown. The operating handle1120 a is similar to the operating handle 1120 described above, butdiffers in the structure of the resheathing lock, although thefunctioning of the resheathing lock is similar to that of theresheathing lock 1044 of operating handle 1020.

Rather than having a resheathing lock mechanism that includes a slotthat is closed on both ends, such as the slot 1038 described above inconnection with the operating handle 1020, the operating handle 1120 ahas a frame 1130 a that includes a protuberance 1139 that defines theproximal end of a recess 1138 a that is open on the distal end. Theprotuberance 1139 is positioned on the frame 1130 a in substantially thesame position as the proximal end 1038″ of the slot 1038 is positionedin the operating handle 1020.

During staged deployment of a prosthetic valve, when the locking pin1155 contacts the protuberance 1139, the proximal movement of thecarriage assembly 1140 is stopped. While the resheathing lock 1144 is inthe locked position (shown in FIG. 20), the valve can be resheathed andrepositioned if desired. When it is desired to fully deploy the valve,the user can unlock the resheathing lock 1144 by sliding the cam member1160 proximally in the slot 1146 to retract the locking pin 1155 fromthe recess 1138 a so that the protuberance 1139 no longer limits theproximal movement of the carriage assembly 1140. The carriage assembly1140 is thus free to further move proximally and enable the valve to befully deployed.

Referring now to FIG. 21, an operating handle 1120 b in accordance witha still further embodiment of the invention is shown. The operatinghandle 1120 b is similar to the operating handles 1120 and 1120 adescribed above, but differs in the structure of the resheathing lock,although the functioning of the resheathing lock is similar to that ofthe resheathing lock 1044 of the operating handle 1020.

Rather than having a resheathing lock that includes a slot that isclosed on both ends, such as the slot 1038 described above in connectionwith the operating handle 1020, or a recess that is closed on one end,such as the recess 1138 a described above in connection with theoperating handle 1120 a, the operating handle 1120 b includes a carriageassembly 1140 b and a resheathing lock member 1155 b that projectsthrough the side rail 1131 b of the frame 1130 b and into the elongatedspace 1134 so as to obstruct the path of travel of the carriage assembly1140 b in the proximal direction. As such, the resheathing lock member1155 b defines the initial distance that the carriage assembly 1140 bmay travel before full deployment of the valve occurs. The resheathinglock member 1155 b may be moved to an unlocked position by retractingthe lock member by a sufficient amount that it no longer protrudes intothe space 1134. With the resheathing lock member 1155 b in the unlockedposition, the carriage assembly 1140 b may continue to move proximally,thereby allowing for full deployment of the valve. Optionally, thelocking member 1155 b may be designed to be fully removable from theframe 1130 b and disposable.

Referring now to FIG. 22, an exemplary transapical delivery device 1210for a collapsible prosthetic heart valve (or other types ofself-expanding collapsible stents) has a catheter assembly 1216 fordelivering the heart valve to and deploying the heart valve at a targetlocation, and an operating handle 1220 for controlling deployment of thevalve from the catheter assembly. The delivery device 1210 extends froma proximal end 1212 to a distal tip 1214. The catheter assembly 1216 isadapted to receive a collapsible prosthetic heart valve (not shown) in acompartment 1223 defined around a tubular support shaft 1221 and coveredby a distal sheath 1224.

The support shaft 1221 extends between a pair of spaced retainers 1225and 1227 affixed thereto and defining the ends of the compartment 1223.A collapsible prosthetic valve may be assembled around the support shaft1221 and between the retainers 1225 and 1227 in the compartment 1223.

The distal sheath 1224 surrounds the support shaft 1221 and is slidablerelative to the support shaft such that it can selectively cover oruncover the compartment 1223. The distal sheath 1224 is affixed at itsdistal end to the distal tip 1214, and its proximal end 1229 abuts theretainer 1227 when the distal sheath is fully covering the compartment1223, as shown in FIG. 22. The proximal end 1229 of the distal sheath1224 is spaced apart from the retainer 1227 when the compartment 1223 isat least partially uncovered.

The delivery device further includes an outer shaft 1222, the proximalend of which is connected to the operating handle 1220, and the distalend of which is connected to the retainer 1227. An inner shaft 1226extends through the operating handle 1220 and the support shaft 1221 tothe distal tip 1214. The connection of the distal sheath 1224 to thedistal tip 1214 thus enables the inner shaft 1226 to control themovement of the distal sheath both proximally and distally.

The operating handle 1220 is adapted to control deployment of aprosthetic valve located in the compartment 1223 by permitting a user toselectively slide the inner shaft 1226 and the attached distal sheath1224 distally or proximally relative to the support shaft 1221, therebyrespectively uncovering or covering the compartment with the distalsheath. The proximal end of the outer shaft 1222 is affixed to an outerframe 1230 of the operating handle 1220, and the proximal end of theinner shaft 1226 is affixed to a carriage assembly 1240 of the operatinghandle that is slidable along a longitudinal axis of the frame, suchthat a user can selectively slide the inner shaft relative to the outershaft by sliding the carriage assembly relative to the frame. Ahemostasis valve 1228 provides an internal gasket adapted to create aseal between the inner shaft 1226 and the proximal end of the outershaft 1222. The strength of this seal may be adjusted by a gasketadjustment wheel 1242 that functions in substantially the same manner asthe adjustment wheel 1042 described above.

The frame 1230 includes a pair of side rails 1231 joined at the proximalend 1212 by an end member 1232 and at the distal end by an end member1233. Collectively, the side rails 1231, the end member 1232, and theend member 1233 define an elongated space 1234 in the frame 1230 inwhich the carriage assembly 1240 may travel.

The carriage assembly 1240 is shown in FIG. 22 without a threaded rod ora deployment actuator, such as described above in connection with theoperating handle 1020. However, it will be appreciated that theoperating handle 1220 may have the same components as are provided atthe distal end member 1033 of operating handle 1020, but thesecomponents would be arranged at the proximal end 1212 of the handle1220. That is, the proximal end member 1232 of the operating handle 1220may have an enlarged bore sized to slidingly receive a threaded rodextending from the proximal end of the carriage assembly 1240. Adeployment actuator may be threadedly assembled on the threaded rodbetween the carriage assembly 1240 and the proximal end member 1232 ofthe frame 1230 such that rotation of the deployment actuatorcontrollably urges the carriage assembly distally within the elongatedspace 1234. Moreover, the deployment actuator may be longitudinallyfixed relative to the proximal end member 1232 such that rotation of thedeployment actuator in the opposite direction causes the carriageassembly 1240 to move proximally relative to the frame 1230.

The operating handle 1220 may also include one or more lock mechanismsadapted to prevent accidental partial or full deployment of a prostheticvalve located in the compartment 1223. Thus, as with all of theoperating handles described above, the operating handle 1220 may includea deployment lock for preventing a user from accidentally initiatingdeployment of a valve, as well as a resheathing lock for preventing theuser from accidentally completing deployment of the valve. Thestructures of these lock mechanisms may be similar to the structures ofany of the lock mechanisms described above, but modified to limit themovement of the carriage assembly 1240 distally relative to the frame1230. For example, the lock mechanism may be similar to that included inthe operating handle 1120 b shown and described with reference to FIG.21, except that the resheathing lock member 1255 that projects throughthe side rail 1231 of the frame 1230 and into the elongated space 1234is located distally of the carriage assembly 1240 (as opposed toproximally as in FIG. 21). Thus, the resheathing lock member 1255defines the initial distance which the carriage assembly 1240 may travelin the distal direction before full deployment of the valve occurs.

The operation of the operating handle 1220 to deploy a prosthetic valvefrom the compartment 1223 is similar to the operation of the operatinghandle 1020 described above with reference to FIGS. 11-17, except thatthe operating handle 1220, as shown, does not include a deploymentactuator to provide the user with mechanical advantage. After moving thedeployment lock, if any, to an unlocked condition, the user can graspthe carriage assembly 1240 and push the same distally within theelongated space 1234 in the frame 1230, which thereby pushes the distalsheath 1224 distally relative to the compartment 1223 and exposes andinitiates deployment of the valve located therein.

Since the resheathing lock member 1255 is in the locked position,movement of the carriage assembly 1240 distally may continue only untilthe distal end of the carriage assembly contacts the lock member. Atthis juncture, the distal sheath 1224 will not fully uncover thecompartment 1223, and the prosthetic valve will not be fully deployed.Therefore, if the user desires to resheath and reposition the valvebefore full deployment, the user can do so by grasping the carriageassembly 1240 and sliding it proximally within the frame 1230 until thecarriage assembly contacts the proximal end 1232 of the frame. Once thevalve has been properly positioned, the deployment operation may becompleted by withdrawing the resheathing lock member 1255 to theunlocked position and moving the carriage assembly 1240 further distallyuntil the valve is fully deployed.

Although the operating handles have been described herein as having oneor two resheathing locks, any number of resheathing locks may be used,with or without a deployment lock, resulting in any number of stages inthe deployment process. For example, there may be three, four, five, sixor more resheathing locks, which thus enable the deployment procedure tobe controlled incrementally.

More particularly, if a user desires, for example, a two-stagedeployment process, a single resheathing lock may be used, resulting inan unsheathing of perhaps about 80% to about 90% of the valve in a firstdeployment stage, followed by an unsheathing of the remaining about 10%to about 20% of the valve in a second deployment stage.

If the user desires a three-stage deployment process, on the other hand,a single resheathing lock may be used with a deployment lock, resultingin a first deployment stage in which no deployment can occur, a seconddeployment stage in which, for example, about 80% to about 90% of thevalve is unsheathed, and a third deployment stage in which the remainingabout 10% to about 20% of the valve is unsheathed.

Still further, if the user desires a four-stage deployment process, tworesheathing locks may be used with a deployment lock, resulting in afirst deployment stage in which no deployment can occur, a seconddeployment stage in which, for example, about 50% of the valve isunsheathed, a third deployment stage in which, for example, about 80% toabout 90% of the valve is unsheathed, and a fourth deployment stage inwhich the remaining about 10% to about 20% of the valve is unsheathed.This last process may be modified to a three-stage deployment process byomitting the deployment lock while keeping the two resheathing locks.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A prosthetic heart valve, comprising: acollapsible and expandable stent extending in a longitudinal directionbetween a proximal end and a distal end, the stent including an annulussection adjacent the proximal end, an aortic section adjacent the distalend, a plurality of commissure features disposed in the annulus section,and a plurality of closed cells disposed continuously in annular rowsaround a circumference of the stent, each of the cells having a shapeformed by a plurality of struts; a collapsible and expandable valveassembly disposed within the annulus section between the proximal end ofthe stent and the plurality of commissure features, the valve assemblyincluding a plurality of leaflets connected to the plurality ofcommissure features; and a cuff disposed in the annulus section, thecuff covering the entirety of each of the cells in a proximal annularrow of cells and the entirety of selected ones of the cells in anannular row of cells adjacent to the proximal annular row, the selectedcells being positioned between one of the commissure features and thecells in the proximal annular row of cells, the cuff having a distaledge including a zig-zag pattern of peaks pointing toward the proximalend of the stent alternating with peaks pointing toward the distal endof the stent, the peaks pointing toward the distal end of the stentincluding a first group of peaks extending a first distance toward thedistal end of the stent alternating with a second group of peaksextending a second distance toward the distal end of the stent, thesecond distance being less than the first distance.
 2. The prostheticheart valve as claimed in claim 1, wherein the struts at the proximalend of the stent form a zig-zag pattern of peaks pointing toward theproximal end of the stent alternating with peaks pointing toward thedistal end of the stent, and the cuff has a proximal edge including azig-zag pattern of peaks pointing toward the proximal end of the stentalternating with peaks pointing toward the distal end of the stent, thecuff being disposed in the annulus section so that the proximal edge ofthe cuff is aligned with the struts at the proximal end of the stent. 3.The prosthetic heart valve as claimed in claim 1, wherein each of thepeaks in the first group of peaks has a free end aligned in a radialdirection of the stent with one of the commissure features.
 4. Theprosthetic heart valve as claimed in claim 1, wherein each of thecommissure features is disposed between a cell in one annular row andanother cell in an adjacent annular row.
 5. A prosthetic heart valve,comprising: a collapsible and expandable stent extending in alongitudinal direction between a proximal end and a distal end, thestent including an annulus section adjacent the proximal end, an aorticsection adjacent the distal end, a transition section between the aorticsection and the annulus section, and a plurality of closed cellsdisposed continuously in annular rows around a circumference of thestent; a plurality of commissure features disposed at a juncture betweenthe annulus section and the transition section, each of the commissurefeatures being disposed at an intersection of four of the closed cells;a collapsible and expandable valve assembly disposed within the annulussection between the proximal end of the stent and the plurality ofcommissure features, the valve assembly including a plurality ofleaflets connected to the plurality of commissure features; and a cuffdisposed in the annulus section, the cuff having a distal edge includinga zig-zag pattern of peaks pointing toward the proximal end of the stentalternating with peaks pointing toward the distal end of the stent, thepeaks pointing toward the distal end of the stent including a firstgroup of peaks extending a first distance toward the distal end of thestent and a second group of peaks extending a second distance toward thedistal end of the stent, the second distance being less than the firstdistance.
 6. The prosthetic heart valve as claimed in claim 5, whereinthe cuff has a scalloped proximal edge.
 7. The prosthetic heart valve asclaimed in claim 5, wherein the four cells include two cells in one ofthe annular rows, a cell in an annular row adjacent one side of the oneannular row and a cell in an annular row adjacent an opposite side ofthe one annular row.
 8. The prosthetic heart valve as claimed in claim5, wherein the stent has a length from the proximal end to the distalend, and the plurality of commissure features are positioned at adistance from the distal end, the distance being about ⅔ of the length.9. The prosthetic heart valve as claimed in claim 5, wherein the peaksin the first group of peaks alternate with the peaks in the second groupof peaks.
 10. The prosthetic heart valve as claimed in claim 5, whereineach of the peaks in the first group of peaks has a free end aligned ina radial direction of the stent with one of the commissure features. 11.A method of deploying a prosthetic heart valve at a target site, themethod comprising: introducing a delivery device to the target site, thedelivery device housing a prosthetic heart valve in a collapsedcondition and having an outer sheath surrounding the prosthetic heartvalve, the prosthetic heart valve including a collapsible and expandablestent having a proximal end, a distal end, an annulus section adjacentthe proximal end, an aortic section adjacent the distal end, a pluralityof cells having a closed shape disposed continuously in annular rowsaround a circumference of the stent from the proximal end to the distalend, each of the cells being formed by a plurality of struts and havinga first end pointing toward the distal end of the stent and a second endpointing toward the proximal end of the stent, the first end of eachcell in a group of cells in the annulus section being connected directlyto the second end of an adjacent cell, the stent including a pluralityof commissure features disposed in the annulus section, each of thecommissure features being disposed entirely between the first end of onecell in one annular row and the second end of another cell in anadjacent annular row, and a collapsible and expandable valve assemblydisposed entirely within the annulus section between the proximal end ofthe stent and the plurality of commissure features; withdrawing thesheath a first distance to partially deploy the prosthetic heart valveat the target site, the prosthetic heart valve being deployed from theproximal end of the stent toward the distal end of the stent such thatthe valve assembly is fully deployed at the first distance and canfunction as intended while the distal end of the stent is held withinthe sheath of the delivery device; resheathing the prosthetic heartvalve; and withdrawing the sheath the first distance to again partiallydeploy the prosthetic heart valve at the target site, the prostheticheart valve being deployed from the proximal end of the stent toward thedistal end of the stent such that the valve assembly is fully deployedat the first distance and can function as intended while the distal endof the stent is held within the sheath of the delivery device.
 12. Themethod of claim 11, further comprising withdrawing the sheath so as tofully deploy the prosthetic heart valve.
 13. A method of testing theoperability of a prosthetic heart valve at a target site, the methodcomprising: introducing a delivery device to the target site, thedelivery device housing a prosthetic heart valve in a collapsedcondition and having an outer sheath surrounding the prosthetic heartvalve, the prosthetic heart valve including a collapsible and expandablestent having a proximal end, a distal end, an annulus section adjacentthe proximal end, an aortic section adjacent the distal end, a pluralityof cells having a closed shape disposed continuously in annular rowsaround a circumference of the stent from the proximal end to the distalend, each of the cells being formed by a plurality of struts and havinga first end pointing toward the distal end of the stent and a second endpointing toward the proximal end of the stent, the first end of eachcell in a group of cells in the annulus section being connected directlyto the second end of an adjacent cell, the stent including a pluralityof commissure features disposed in the annulus section, each of thecommissure features being disposed entirely between the first end of onecell in one annular row and the second end of another cell in anadjacent annular row, and a collapsible and expandable valve assemblydisposed entirely within the annulus section between the proximal end ofthe stent and the plurality of commissure features; withdrawing thesheath a first distance to partially deploy the prosthetic heart valveat the target site, the prosthetic heart valve being deployed from theproximal end of the stent toward the distal end of the stent such thatthe valve assembly is fully deployed at the first distance and canfunction as intended while the distal end of the stent is held withinthe sheath of the delivery device; and assessing valve function when theprosthetic heart valve is partially deployed and resheathing theprosthetic heart valve.
 14. The method of claim 13, wherein introducingthe delivery device to the target site includes introducing the deliverydevice to a target site in vitro.
 15. The method of claim 13, whereinintroducing the delivery device to the target site includes introducingthe delivery device to a target site in a mammal.
 16. The method ofclaim 13, wherein introducing the delivery device to the target siteincludes introducing the delivery device to a target site in a humanpatient.
 17. A system, comprising: a delivery device having avalve-receiving compartment and a sheath slidable relative to thevalve-receiving compartment; and a prosthetic heart valve disposed inthe valve-receiving compartment, the prosthetic heart valve including acollapsible and expandable stent having a proximal end, a distal end, anannulus section adjacent the proximal end, an aortic section adjacentthe distal end, and a plurality of cells having a closed shape disposedcontinuously in annular rows around a circumference of the stent fromthe proximal end to the distal end, each of the cells being formed by aplurality of struts and having a first end pointing toward the distalend of the stent and a second end pointing toward the proximal end ofthe stent, the first end of each cell in a group of cells in the annulussection being connected directly to the second end of an adjacent cell,the annulus section having a first expanded cross-section and the aorticsection having a second expanded cross-section larger than the firstexpanded cross-section, the stent including a plurality of commissurefeatures disposed in the annulus section, each of the commissurefeatures being disposed entirely between the first end of one cell inone annular row and the second end of another cell in an adjacentannular row, and a collapsible and expandable valve assembly disposedentirely within the annulus section between the proximal end of thestent and the plurality of commissure features, the valve assemblyincluding a plurality of leaflets connected to the plurality ofcommissure features, the sheath being withdrawn from around theprosthetic valve to expose the commissure features, wherein the valveassembly is free to operate as intended in a portion of the stent notretained by the sheath.
 18. A system, comprising: a delivery devicehaving a valve-receiving compartment and a sheath slidable relative tothe valve-receiving compartment; and a prosthetic heart valve disposedin the valve-receiving compartment, the prosthetic heart valve includinga collapsible and expandable stent having a proximal end, a distal end,an annulus section adjacent the proximal end, an aortic section adjacentthe distal end, and a plurality of cells having a closed shape disposedcircumferentially in annular rows around a circumference of the stentfrom the proximal end to the distal end, each of the cells being formedby a plurality of struts and having a first end pointing toward thedistal end of the stent and a second end pointing toward the proximalend of the stent, the first end of each cell in a group of cells in theannulus section being connected directly to the second end of anadjacent cell, the annulus section having a first expanded cross-sectionand the aortic section having a second expanded cross-section largerthan the first expanded cross-section, the stent including a pluralityof commissure features disposed in the annulus section, each of thecommissure features being disposed entirely between the first end of onecell in one annular row and the second end of another cell in anadjacent annular row, and a collapsible and expandable valve assemblydisposed entirely within the annulus section between the proximal end ofthe stent and the plurality of commissure features, the valve assemblyincluding a plurality of leaflets connected to the plurality ofcommissure features, the sheath being movable from a first configurationin which the sheath is partially withdrawn from around the prostheticvalve to expose the commissure features so that the valve assembly isfree to operate as intended in a portion of the stent not retained bythe sheath, and a second configuration in which the sheath substantiallycompletely covers the stent and the valve assembly is incapable ofoperating as intended.